Cytomedix Receives FDA Clearance for AutoloGel

The FDA has granted clearance for Cytomedix Inc. to market its platelet rich plasma (PRP) gel produced under the AutoloGel System name to be used under the supervision of a healthcare professional for exuding wounds, such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

Cytomedix is the first company in the U.S. to complete a randomized, controlled, multicenter, double-blinded, clinical trial for a PRP gel system for use on chronic wounds. The company’s clinical trial results demonstrate healing rates of 68 percent and 81 percent for AutoloGel treated patients achieving total wound closure in the per-protocol (i.e., patients treated as provided in the study protocol) and majority-wound (i.e., wound sizes smaller than 7 square centimeters in the per-protocol cohort) groups respectively. These are higher healing rates than those in any other similar data for other chronic wound treatment products with which the company is familiar.